PMA P010025

Device: HOLOGIC SELENIA DIMENSIONS 2D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
Applicant: Hologic, Inc.
PMA number: P010025
Supplement: S019
Product code: MUE
Decision date: 2010-11-16
Generic name: Full field digital, system, x-ray, mammographic
Approval order statement: APPROVAL FOR ADDITIONAL AUTOMATIC EXPOSURE CONTROL (AEC) TECHNIQUE TABLES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SELENIA DIMENSIONS 2D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM.

Current openFDA PMA Record#

Device: HOLOGIC SELENIA DIMENSIONS 2D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
Applicant: Hologic, Inc.
PMA number: P010025
Supplement: S019
Product code: MUE
Generic name: Full field digital, system, x-ray, mammographic
Decision date: 2010-11-16
Decision code: APPR
Date received: 2010-06-01
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR ADDITIONAL AUTOMATIC EXPOSURE CONTROL (AEC) TECHNIQUE TABLES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SELENIA DIMENSIONS 2D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM.